CRA assessed commercial efforts to develop and commercialize a MS drug with respect to obligations stemming from the acquisition of Genzyme Corporation by Sanofi-Aventis following shareholder concerns. In particular, CRA assessed the development strategy for the drug, including an assessment of its launch market access strategy and pricing strategy in various countries in the context of the drug’s attributes and existing available treatments. Further, CRA assessed Plaintiff theories of appropriate commercialization in connection with the achievement of contingent milestones associated with commercial sales.
New DOJ guidelines focus the fight against white-collar crime
Concurrently, the DOJ has updated its Corporate Enforcement Policy (CEP), providing guidance on how self-disclosure, cooperation, and remediation efforts can...